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ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer (ZANTE)

Primary Purpose

Metastatic Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

Italy

Study Type

Interventional

Intervention

docetaxel

zoledronic acid

About this trial

This is an interventional treatment trial for Metastatic Prostate Cancer focused on measuring hormone refractory, bone metastasis, chemotherapy, biphosphonates

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent
Hormone refractory prostate cancer
Stage IV disease with bone metastasis
No immunotherapy, hormonal therapy or radiotherapy within the previous month
Performance status < or = 2 (ECOG)
Serum creatinine < 1.5 mg/100ml
Serum bilirubin < or = 1.25 x UNL (upper normal limit) (or < or = 1.5 x UNL in the presence of hepatic metastases); SGOT e SGPT < or = 1.5 x UNL (or < or = 2.5 x UNL in presence of hepatic metastases)
Left ventricular ejection fraction > or = 50% (measured by cardiac ultrasound or MUGA scan)
Neutrophils > 1500/mm3; platelets >100000/mm3; hemoglobin >10 g/100 ml· Life expectancy of at least 3 months

Exclusion Criteria:

Previous malignancies with the exception of radically treated epithelioma
Previous chemotherapy
Comorbidities that would, in the Investigator's opinion, contraindicate the use of the drugs in the study
Uncontrolled Diabetes
Severe cardiac arrhythmias, severe uncontrolled congestive heart failure, severe ischemic cardiac disease or myocardial infarction within the previous 6 months
severe infection
cerebral metastasis
Pre-existing motor or sensory neurotoxicity > or = grade 2 according to CTC (Common Toxicity Criteria).

Sites / Locations

Istituto Nazionale dei Tumori
Ospedale Oncologico Regionale C.R.O.B. - Basilicata

Outcomes

Primary Outcome Measures

to determine the maximum tolerated dose and dose limiting toxicity of docetaxel in the two treatment schedules

Secondary Outcome Measures

to determine the recommended docetaxel dose when combined with zoledronic acid for phase II studies

to determine which administration sequence of the combination permits a higher dosage of docetaxel

to describe the toxicity of the combination of the two drugs

to describe the effects of the combination of the two drugs on biologic parameters: angiogenetic factors, cytokines, differential neuroendocrine markers, serum markers of osteolysis

to describe the antitumor activity of the two drug association

Full Information

NCT ID

NCT00415779

First Posted

December 22, 2006

Last Updated

February 23, 2010

Sponsor

National Cancer Institute, Naples

1. Study Identification

Unique Protocol Identification Number

NCT00415779

Brief Title

ZANTE: Zometa and Taxotere in Hormone Refractory Prostate Cancer

Acronym

ZANTE

Official Title

Phase I Study of the Combination of Zoledronic Acid and Docetaxel in Patients With Hormone Refractory Metastatic Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Institute, Naples

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This phase I trial is studying the side effects and best dose of docetaxel when given with zoledronic acid in patients with bone metastasis from prostate cancer that has not responded to hormone therapy.

Detailed Description

Docetaxel has been used alone and in combination with other anti-cancer therapies in the treatment of hormone refractory metastatic prostate cancer. Zoledronic acid has been used in the treatment of bone metastasis from prostate cancer. This is a study of the combination of these two agents. The Zante study will test a dose escalation of docetaxel in association with a predetermined dose of zoledronic acid (2 mg), given every 14 days for a minimum of 6 and maximum of 12 cycles. Sequence A: Docetaxel on day 1 and zoledronic acid on day 2 Sequence B: Zoledronic acid on day 1 and docetaxel on day 2 Patients are enrolled sequentially in cohorts of 3 for each dose level, and a maximum of 36 patients will be enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Prostate Cancer

Keywords

hormone refractory, bone metastasis, chemotherapy, biphosphonates

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

docetaxel

Intervention Description

given IV in subsequent cohorts of patients at 30, 40, or 50mg/m2

Intervention Type

Drug

Intervention Name(s)

zoledronic acid

Intervention Description

2 mg IV every 2 weeks

Primary Outcome Measure Information:

Title

to determine the maximum tolerated dose and dose limiting toxicity of docetaxel in the two treatment schedules

Time Frame

every 2 weeks for up to 3 cycles

Secondary Outcome Measure Information:

Title

to determine the recommended docetaxel dose when combined with zoledronic acid for phase II studies

Time Frame

every 2 weeks for 6 cycles

Title

to determine which administration sequence of the combination permits a higher dosage of docetaxel

Time Frame

every 2 weeks for 6 weeks

Title

to describe the toxicity of the combination of the two drugs

Time Frame

every 2 weeks

Title

to describe the effects of the combination of the two drugs on biologic parameters: angiogenetic factors, cytokines, differential neuroendocrine markers, serum markers of osteolysis

Time Frame

every 12 weeks

Title

to describe the antitumor activity of the two drug association

Time Frame

every 12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent Hormone refractory prostate cancer Stage IV disease with bone metastasis No immunotherapy, hormonal therapy or radiotherapy within the previous month Performance status < or = 2 (ECOG) Serum creatinine < 1.5 mg/100ml Serum bilirubin < or = 1.25 x UNL (upper normal limit) (or < or = 1.5 x UNL in the presence of hepatic metastases); SGOT e SGPT < or = 1.5 x UNL (or < or = 2.5 x UNL in presence of hepatic metastases) Left ventricular ejection fraction > or = 50% (measured by cardiac ultrasound or MUGA scan) Neutrophils > 1500/mm3; platelets >100000/mm3; hemoglobin >10 g/100 ml· Life expectancy of at least 3 months Exclusion Criteria: Previous malignancies with the exception of radically treated epithelioma Previous chemotherapy Comorbidities that would, in the Investigator's opinion, contraindicate the use of the drugs in the study Uncontrolled Diabetes Severe cardiac arrhythmias, severe uncontrolled congestive heart failure, severe ischemic cardiac disease or myocardial infarction within the previous 6 months severe infection cerebral metastasis Pre-existing motor or sensory neurotoxicity > or = grade 2 according to CTC (Common Toxicity Criteria).

Overall Study Officials: